DEXTRAGEL ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

DEXTRAGEL ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

DEXTRAGEL ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Dextra Gel, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 75% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hands thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15-30°C (59-86˚F)
• avoid freezing and excessive heat above 40˚C (104˚F)

Inactive ingredients

glycerin, carbomer, triethanolamine, water

Questions? +1-888-385-4685

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

CONVENIENT EASY TO TEAR PACKETS

Clean Hands on the Go

A Simple Decision in an Uncertain World

Our convenient sanitizer packets provide the highest level of clean when soap and water are not within reach.

Each packet fits in the palm of your hand, providing a 2 mL measured amount. The easy tear packet allows for quick sanitizing and disposal for your valued customers, keeping them and their families safe.

Easy Tear Packs

Nontoxic

Distributed by: Dextragel LLC - Kennedale, TX 76060

Country of origin: China

www.dextragel.com

Packaging

INGREDIENTS AND APPEARANCE

DEXTRAGEL ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80209-098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80209-098-30	50 in 1 BAG	11/29/2020
1		2 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/29/2020

Labeler - Dextra Gel, Llc (117594541)